LEVITRA Drug Patent Profile
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Which patents cover Levitra, and what generic alternatives are available?
Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levitra
A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
Summary for LEVITRA
| International Patents: | 54 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 26 |
| Patent Applications: | 5,451 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVITRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVITRA |
| What excipients (inactive ingredients) are in LEVITRA? | LEVITRA excipients list |
| DailyMed Link: | LEVITRA at DailyMed |
Recent Clinical Trials for LEVITRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Respira Therapeutics, Inc. | Phase 1 |
| A2 Healthcare Taiwan Corporation | Phase 1/Phase 2 |
| Tritech Biopharmaceuticals Co., Ltd. | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for LEVITRA
Paragraph IV (Patent) Challenges for LEVITRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LEVITRA | Tablets | vardenafil hydrochloride | 2.5 mg | 021400 | 1 | 2009-09-04 |
| LEVITRA | Tablets | vardenafil hydrochloride | 5 mg and 10 mg | 021400 | 1 | 2009-07-10 |
| LEVITRA | Tablets | vardenafil hydrochloride | 20 mg | 021400 | 1 | 2009-03-05 |
US Patents and Regulatory Information for LEVITRA
LEVITRA is protected by two US patents.
Patents protecting LEVITRA
Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVITRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVITRA
See the table below for patents covering LEVITRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 228196 | 2-PHENYL SUBSTITUTED IMIDAZOTRIAZINONES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Try a Trial |
| Norway | 20002444 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 9924433 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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